Label: GY-NA-TREN - boric acid, lactobacillus acidophilus, vitamin c

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 04/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Boricum Acidum HPUS 3X

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  • PURPOSE

    Antiseptic

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  • INDICATIONS & USAGE

    temporarily relieves symptoms associated with vaginal yeast infections

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  • WARNINGS

    For vaginal use only.

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  • DO NOT USE

    Do not

    • ingest
    • use if you are pregnant or suspect you are pregnant
    • use while using a tampon
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  • ASK DOCTOR

    Ask a doctor before use if you are

    • experiencing vaginal pain
    • having a high fever
    • experiencing vaginal discharge with a foul smell
    • under a doctor's care for any serious condition
    • taking any other drug


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  • STOP USE

    Stop use and ask a doctor if you experience

    • vaginal pain
    • high fever
    • severe irritation or burning
    • vaginal discharge with a foul smell
    • symptoms persisting for more than 14 days or if they clear up and occur again within a few days
    • a worsening condition


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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • wash hands before use
    • when vaginal area is clean and dry, using your index finger, gently insert yellow capsule into your vagina as far as comfortable
    • adults and children over 12 years of age:  insert one capsule daily before bedtime.  Repeat for 14 consecutive days.
    • children under 12 years of age: consult a doctor
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  • STORAGE AND HANDLING


    • keep dry and refrigerated
    • tamper evident: do not use if seal on bottle is broken
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  • INACTIVE INGREDIENT

    Cellulose powder, dehydrated potato powder, gelatin, L-leucine, microcrystalline cellulose

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  • QUESTIONS

    Questions or Comments?

    Call 1-800-992-3323 between 7am and 4pm PST

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  • INGREDIENTS AND APPEARANCE
    GY-NA-TREN 
    boric acid, lactobacillus acidophilus, vitamin c kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:32267-920
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32267-920-14 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 14 
    Part 2 14 
    Part 1 of 2
    GY-NA-TREN 
    lactobacillus acidophilus, vitamin c capsule
    Product Information
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LACTOBACILLUS ACIDOPHILUS (LACTOBACILLUS ACIDOPHILUS) LACTOBACILLUS ACIDOPHILUS 5000000000 [CFU]
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 3 mg
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE  
    LEUCINE  
    Product Characteristics
    Color yellow (none) Score no score
    Shape CAPSULE (none) Size 23mm
    Flavor Imprint Code none
    Contains     
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 04/30/2012
    Part 2 of 2
    GY-NA-TREN 
    boric acid suppository
    Product Information
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BORIC ACID (BORIC ACID) BORIC ACID 3 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    POWDERED CELLULOSE  
    GELATIN  
    CELLULOSE, MICROCRYSTALLINE  
    LEUCINE  
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/30/2012
    Labeler - Natren Inc. (139705693)
    Registrant - Natren Inc. (139705693)
    Establishment
    Name Address ID/FEI Business Operations
    Natren Inc. 139705693 manufacture
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